In China, the number of people suffering from attention deficit hyperactivity disorder (ADHD) has exceeded 34 million. For a long time, the clinical treatment of this group has been heavily reliant on imported drugs.

With the launch of the first generic drug by Lifang Pharmaceutical, the approval of multiple dosage forms of improved new drugs by Youer Pharmaceutical, and the successful approval of innovative compound preparations by Aikebaifa, several domestically produced ADHD treatment drugs have been launched, and the reliance on imported drugs is gradually being broken.

In the ADHD sector, a breakthrough battle for domestic substitution and upgrading has officially begun.

01

Market potential awaits release

Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder characterized by disproportionate attention deficits and hyperactivity, manifesting as poor concentration, impulsivity, hyperactivity, and learning difficulties. According to the "Pediatric Expert Consensus on Early Identification, Standardized Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (2020)," the prevalence of ADHD among children and adolescents in China is approximately 6.26%, affecting about 23 million people, but the clinical consultation rate is only about 10% . Data shows that up to 65% of children with ADHD retain related symptoms into adulthood, severely impacting their learning and work efficiency, social functioning, and mental health.

In China, the prevalence of ADHD is steadily increasing. As of 2024, there were approximately 34 million people with ADHD in China, 45% of whom were children and adolescents aged 6-17. This patient population is projected to grow at a compound annual growth rate of 1.3% over the next decade, exceeding 39.2 million by 2035. This large patient base provides ample room for growth in the treatment drug market.

Currently, due to insufficient public awareness of ADHD and the limited variety of clinically available drugs, the market size of ADHD treatment drugs in China is estimated at 1.1 billion yuan in 2024 .

However, with the continued increase in public attention to mental health, coupled with the approval of more innovative drugs and the continuous improvement of standardized diagnosis and treatment, the domestic ADHD drug market is expected to enter a period of rapid growth. According to industry forecasts, by 2035, the Chinese ADHD treatment drug market will reach 13.1 billion yuan , with a compound annual growth rate of 24.9% from 2024 to 2035, making it a promising sub-sector in the pharmaceutical industry.

02

Breakthrough of domestic drugs

Currently, ADHD treatment primarily relies on a combination of medication and non-medication approaches. Medication treatment includes stimulants (which act on dopamine receptors and have a rapid onset of action) and non-stimulants (which act on norepinephrine and have a slower onset of action). Stimulants are more effective, but they have drawbacks such as short duration of action and the potential risk of abuse.

Methylphenidate hydrochloride extended-release tablets are a central nervous system stimulant, belonging to the class of psychotropic drugs. They primarily work by acting on the dopamine system to rapidly improve symptoms of attention deficit hyperactivity disorder (ADHD), and are listed as a first-line treatment in ADHD prevention and treatment guidelines in many countries worldwide. Developed by Janssen Pharmaceuticals, the original manufacturer, methylphenidate hydrochloride extended-release tablets received FDA approval in the United States in 2000. It entered the Chinese market in 2005 under the brand name Concerta, initially focusing on childhood ADHD, but was subsequently approved for use in adolescents and adults, becoming one of the "gold standard" drugs in the domestic ADHD treatment field.

Benefiting from the increased diagnosis rate of ADHD in China and the release of patient demand for medication, the demand for methylphenidate hydrochloride extended-release tablets in the domestic market has shown a sustained and rapid growth trend. According to data from Yaozhi, the sales of this product in domestic public medical institutions exceeded RMB 500 million in 2024, and are expected to further climb to approximately RMB 550 million in 2025.

For a long time, the domestic market for methylphenidate hydrochloride sustained-release tablets was dominated by the original drug. It wasn't until April 2025 that Lifang Pharmaceutical's methylphenidate hydrochloride sustained-release tablets were officially approved for marketing, breaking the monopoly of imported drugs and becoming the first domestically produced formulation of this product to be approved in China.

Regarding other dosage forms, in January 2024, the oral sustained-release dry suspension of methylphenidate hydrochloride, co-developed by Youer Pharmaceuticals and Tris Pharma, was successfully approved for marketing , with the indication of attention deficit hyperactivity disorder. Previously, the methylphenidate hydrochloride sustained-release chewable tablets co-developed by the two companies were approved for marketing in December 2023 and officially available nationwide in November 2024.

Methylphenidate hydrochloride oral sustained-release dry suspension and methylphenidate hydrochloride sustained-release chewable tablets are improved new drugs developed by Tris Pharmaceuticals , and were approved for marketing in the United States in 2012 and 2015, respectively. Clinical study data showed that both drugs significantly improved the symptoms of ADHD patients within 45 minutes to 12 hours after administration.

In January 2025, Zhongshuai Pharmaceutical's dextromethorphan hydrochloride sustained-release capsules were also successfully approved for marketing , becoming the first generic version of this drug. It is understood that dextromethorphan hydrochloride, as the dextrorotatory isomer of methylphenidate hydrochloride, is used in these capsules with oral pellet absorption technology, containing 50% immediate-release pellets and 50% delayed-release pellets. This drug was approved for marketing in the United States in May 2005 for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged six years and older.

In January 2026, AcoBio's Closiline-Dexpirate Capsules (Aizhida) were approved in China for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. Closiline-Dexpirate Capsules are an ADHD treatment with an innovative mechanism of action, and are the world's first and currently only combination formulation containing immediate-release dextromethorphan (d-MPH) and the prodrug methylphenidate (SDX). This drug was approved in the United States in March 2021, becoming the first next-generation methylphenidate drug to receive FDA approval in nearly two decades. In December 2021, AcoBio acquired a license for Closiline-Dexpirate Capsules from Commave.

Immediate-release methylphenidate is an immediate-release drug that has been used globally for the treatment of ADHD for over 20 years. It has a rapid onset of action within 30 minutes, meeting patients' immediate needs for control of core symptoms. The prodrug flocculant methylphenidate is a prodrug that is slowly converted to d-MPH in the body, effectively improving ADHD symptoms throughout the day and reducing the risk of symptom rebound (or collapse) caused by the rapid drop in d-MPH concentration at night, as is common with traditional methylphenidate extended-release drugs.

Compared to traditional single-drug sustained-release formulations, the biphasic release pharmacokinetic characteristics of compound chlorpheniramine capsules better match the circadian rhythm and lifestyle of ADHD patients, which typically revolve around "waking up in the morning - working, studying, and socializing during the day - doing homework/work in the evening - falling asleep." This innovative design makes it suitable not only for school-aged children and adolescents aged 6 and above, but also for adults with ADHD, while reducing the need for frequent medication and minimizing sleep disruption.

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor used as a first-line treatment for ADHD in children and adolescents. It was originally developed by Eli Lilly. Currently, the domestic production of atomoxetine hydrochloride in China is relatively mature, with dozens of domestic manufacturers approved to produce it, including Huahai Pharmaceutical, Jichuan Pharmaceutical, and Shandong New Era Pharmaceutical. Dosage forms cover various formats such as oral solutions, capsules, and tablets, meeting the needs of different patients and effectively improving the clinical accessibility of this type of drug.

03

Breaking the supply dilemma
Globally, central nervous system stimulants have become the first-line drugs for treating ADHD in most countries due to their significant efficacy. However, because of the potential risk of abuse, their production, distribution, and use are all subject to strict control systems, and China is no exception.

For example, Johnson & Johnson's methylphenidate hydrochloride extended-release tablets (Concerta) are classified as Class I psychotropic drugs under strict national control. Their production and distribution are subject to extremely strict supervision and can only be purchased with a "red prescription" issued by a professional physician. Only attending physicians or above who have passed the assessment for the management of controlled substances can prescribe such drugs after conducting a detailed clinical evaluation of the patient and making a clear diagnosis of ADHD.

In July 2024, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, issued a statement clarifying that Concerta is a Class I psychotropic drug under national control, and its main raw materials are subject to global regulations. Since 2023, influenced by multiple factors such as the increasing global ADHD diagnosis rate and surging patient demand, the global demand for Concerta has continued to grow significantly. Although the company planned to ensure the supply of the drug throughout 2024, global demand still exceeded the company's production capacity limit, making it difficult to quickly alleviate the supply shortage.

In order to alleviate the supply pressure in the domestic market as much as possible, Janssen Pharmaceuticals in Xi'an made it clear at the time that it planned to transfer the packaging process of its drug for the Chinese market from overseas factories to local factories in Xi'an, thereby accelerating the supply of drugs to the Chinese market by optimizing the supply chain layout.

For nearly 20 years, Johnson & Johnson's Concerta has been able to monopolize the domestic methylphenidate hydrochloride extended-release tablet market primarily due to its complex osmotic pump technology and manufacturing process. This technology enables continuous and stable drug release in the body for up to 24 hours, significantly improving therapeutic efficacy and effectively reducing side effects caused by drug concentration fluctuations, thereby greatly enhancing patient safety and adherence. The high barriers to entry in osmotic pump technology have made it difficult for domestic companies to break through, resulting in Concerta's long-standing market dominance.

In recent years, China has attached great importance to the development of the mental health field, especially focusing on the innovation and accessibility of pediatric drugs. A series of supportive policies have been introduced, creating a green channel for the domestic research and development and market launch of ADHD drugs. In 2017, ADHD drugs were included in the "Second Batch of Encouraged Research and Development List of Pediatric Drugs," opening a green channel for the approval of related generic and innovative drugs and accelerating the market launch process. The "Outline for the Development of Children in China (2021-2030)" also explicitly proposes measures to encourage innovation in pediatric drugs and simplify procedures. These policy supports have not only reduced the research and development and market launch costs of ADHD drugs but also increased the enthusiasm of enterprises to participate in this field, injecting policy dividends into market growth.

Generic drugs such as methylphenidate hydrochloride sustained-release tablets from Lifang Pharmaceutical and dextromethorphan hydrochloride sustained-release capsules from Zhongshuai Pharmaceutical have been approved one after another. Youer Pharmaceutical's improved new drug methylphenidate hydrochloride sustained-release chewable tablets and oral sustained-release dry suspension have achieved nationwide supply. Aikebaifa's innovative compound preparation has been successfully launched. Many domestic ADHD drugs have been approved, which not only broke the long-term market monopoly of original drugs, but also alleviated the shortage of medication for ADHD patients in China.

04

Conclusion
In the future, with the continuous improvement of the R&D capabilities of domestic pharmaceutical companies, breakthroughs will be made in dosage form innovation, target innovation, and combination drug regimen innovation for ADHD treatment. The accessibility of medication for domestic patients will be greatly improved. At the same time, the cost-effectiveness advantage of domestically produced drugs will reduce the burden of medication for patients and further promote the standardized development of the domestic ADHD diagnosis and treatment field.

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